Trials / Completed
CompletedNCT02489292
Study to Evaluate the Efficacy of HepaStem in Urea Cycle Disorders Paediatric Patients (HEP002)
Prospective, Open Label, Multicenter, Efficacy and Safety Study of Several Infusions of HepaStem in Urea Cycle Disorders Paediatric Patients
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 5 (actual)
- Sponsor
- Cellaion SA · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
The aim of the study is to assess the efficacy of HepaStem treatment in paediatric patients suffering from urea cycle disorders.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | HepaStem | HepaStem will be administered in maximum 4 infusion days, spread over an 8-week period with an interval of 2 to 3 weeks between infusion days. The target total dose of cells will be 50x10E6 cells/kg body weight |
Timeline
- Start date
- 2014-10-01
- Primary completion
- 2017-03-01
- Completion
- 2017-03-01
- First posted
- 2015-07-03
- Last updated
- 2020-10-19
Locations
6 sites across 4 countries: Belgium, France, Poland, Spain
Source: ClinicalTrials.gov record NCT02489292. Inclusion in this directory is not an endorsement.